Prospective Multicenter Evaluation of a New Predictive Model for the Progression of Adolescent Idiopathic Scoliosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 1,200
- Locations
- 9
- Primary Endpoint
- Change in scoliosis severity based on the 3D reconstruction of the spine at the initial visit and follow ups in a large multicenter prospective study
Study Overview
Brief Summary
Scoliosis is a three-dimensional deformity affecting the orientation and position of the spine. Locally, the shape of the vertebra is also affected. The most common form is adolescent idiopathic scoliosis (AIS) with a prevalence of 1-3% affecting primarily young adolescent females. AIS can either be treated using a brace and in some cases necessitate surgical correction to prevent progressive deformity. Risk factors for progression include female gender, curve magnitude and location, skeletal maturity and growth velocity. However, these risk factors have been shown to be inconsistent in predicting curve progression. Over the past 6 years, the investigators have developed a predictive model of the final Cobb angle in AIS based on 3D spinal parameters. This analysis was based on a prospective cohort of 195 patients that were enrolled upon their initial visit and followed until maturity. This predictive model has a determination coefficient of 0.702. The proposed new study aims at refining and testing the external validity of this model in a larger cohort. The next step towards using the new model in the clinical setting is to redesign the model and to externally validate the model by measuring the agreement between the new method and the traditional Cobb angle at maturity in a larger multicenter study. The objective of this study is to characterize the risk of scoliosis progression based on local three-dimensional vertebral and pelvic measurements present on initial evaluation. Three-dimensional reconstructions will be derived from stereo-radiographs acquired with a new biplanar low-dose radiographic system installed in all 8 clinical sites (EOS system, EOS-Imaging, Paris). These calibrated radiographs will then be used to reconstruct the vertebrae and intervertebral disks at each level as well as the geometry of the pelvis. A series of local and regional parameters will then be calculated from these 3D reconstructions. Correlation analysis will help determine if intervertebral disk wedging, vertebral wedging, transverse plane rotation or pelvic geometry can be used as early predictors of curve progression in AIS.
Identifying a new 3D measure of scoliosis associated with rapid curve progression could help predict which curves need early treatment to prevent further progression. The ultimate goal of this research project will be to validate this new predictive model and finally transfer this new predictive tool in the hands of clinicians treating AIS.
Detailed Description
By identifying the patients for whom the model predicts a significant progression the investigators could focus their efforts on being more pro-active towards brace wear for those at risk of progression. With the advent of new growth modulation techniques, these patients could also potentially receive early management of their curves to prevent further progression and diminish the need for surgical correction and fusion of their curve. Alternatively, by identifying the patients that will not progress immediately at the first visit, the investigators could arguably decrease their number needed to treat from 4 to 2 by removing those patients that won't progress no matter what their treatment is. So, the prediction model will not only have an impact for the patients at risk of progression but will also impact those that are braced despite having a low risk of progression.
Patient enrollment:
Patients who meet the inclusion criteria will be offered enrollment in the project. If the family wishes to enroll in the project, the informed consent process will be undertaken and the patient will be enrolled.
If Patients need to be treated with brace No changes in the usual treatment and monitoring will be instituted. Therefore, patients will be allowed to undergo brace treatment. The investigators are aware that brace treatment could have an impact on curve progression but these patients are still included as progression despite brace treatment may give meaningful information regarding these difficult-to-treat curves. Patient under brace treatment will have to remove brace at least the night before their appointment and follow-up spine radiographs. Also the protocol requires that patients have at least one spine radiograph out of brace every 12 months. Bracing compliance will be evaluated as a specific covariable in the upcoming study. To better understand the impact of bracing on progression, the investigators will be using brace monitors, pressure sensitive transducers that can monitor brace wear and brace effectiveness, in their multicenter study and use the data generated by these monitors as a co-factor in an improved prediction model.
If patients need to have surgery Although patients showing sufficient curve progression to undergo surgical correction will not be kept in the prospective cohort after surgery, their data will still be analyzed to assess the correlation between local 3-D measurements and curve progression.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 10 Years to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Idiopathic Scoliosis (as diagnosed by the surgeon)
- •Patients above 10 year old at the time of recruitment
- •Spina bifida occulta with no neurological signs and otherwise normal
- •Curves ranging between 11º and 40º of Cobb angle measurement and
- •Risser 0 or 1, as measured on a standing postero-anterior digital radiograph of the spine.
- •All single thoracic, thoraco-lumbar, lumbar, double major and triple major curves will be included in the study.
Exclusion Criteria
- •Previous thoracic, pelvis or spine surgery as they may be co-factors in scoliosis initiation,
- •Congenital scoliosis,
- •MRI abnormalities (including > 4mm of Syrinx and/or Chiari malformation)
- •Syndromic scoliosis (associated with Marfan's or other genetic syndromes),
- •Neuromuscular scoliosis,
- •Developmental delay
- •Spinal asymmetry
- •Symptomatic spondylolisthesis
- •Leg length discrepancy longer than 1 cm.
- •Unable or unwilling to firmly commit to returning for required follow-up visits
Outcomes
Primary Outcomes
Change in scoliosis severity based on the 3D reconstruction of the spine at the initial visit and follow ups in a large multicenter prospective study
Time Frame: Baseline, 6 months, 12 months, 18 months, 24 months
The main objective of this study is to validate a predictive model for determining scoliosis severity based on the 3D reconstruction of the spine at the initial visit in a large multicenter prospective study. This objective can be divided in two specific objectives: Objective 1: to improve the determination coefficient of the predictive model by including new findings of a subset of this prospective cohort of patients. Objective 2: to test the external validity of the predictive model
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr Stefan Parent
Orthopaedic surgeon
St. Justine's Hospital